Phase 2
Completed N=67
A Study of SHR-1210 in Combination With Capecitabine + Oxaliplatin or Apatinib in Treatment of Advanced Gastric Cancer
Source: ClinicalTrials.gov NCT03472365 ↗Enrolled (actual)
67
Serious AEs
50.7%
Results posted
Jan 2024
Primary outcomePrimary: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 — 58.3; 10.5 percentage
Summary
The purpose of this trial is to estimate overall response rate (ORR) of SHR-1210 combined with capecitabine and oxaliplatin or with apatinib as first-line treatment in subjects with locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 |
58.3; 10.5 | — |
| SECONDARY Progression-free Survival (PFS) Per RECIST 1.1 |
6.768; 2.793 | — |
| SECONDARY Duration of Response (DOR) Per RECIST 1.1 |
5.749; NA | — |
| SECONDARY Disease Control Rate (DCR) Per RECIST 1.1 |
93.8; 57.9 | — |
| SECONDARY Number of Subjects With Treatment-related Adverse Events (AEs) |
48; 18 | — |
Eligibility Criteria
Inclusion Criteria
- Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic adenocarcinoma of stomach or the esophagogastric junction (GEJ).
- Age ≥ 18 years old, male or female.
- NO previous therapy for advanced/metastatic disease of GC/GEJ (including HER2 inhibitor). Subjects with previous adjuvant/neo-adjuvant therapy completed more than 6 months can be enrolled.
- Has measurable disease per RECIST 1.1.
- Life expectancy ≥ 12 weeks.
- Eastern Cooperative Group (ECOG) performance status of 0 to 1.
- Has adequate organ function.
- Females of childbearing potential (FOCBP), who are not surgically sterile or postmenopausal, must conduct pregnancy test (serum or urine) within 7 days before enrollment, and must not be pregnant or breast-feeding women. If the result is negative, she must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs. And non-sterilized males who are sexually active must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs.
Exclusion Criteria
- Has known HER2-positive status.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody, or a VEGFR inhibitor.
- Has known active central nervous system metastases.
- Has received a live vaccine within 4 weeks prior to the first dose of study treatment.
- With any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
- Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class > 2), or ventricular arrhythmia which need medical intervention.
- Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg.
- Coagulation abnormalities (INR > 1.5 or APTT > 1.5×ULN), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy.
Data sourced from ClinicalTrials.gov (NCT03472365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.